Expired Study
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New York, New York 10021


Purpose:

RATIONALE: High doses of testosterone may be effective in killing prostate cancer cells that no longer respond to hormone therapy. PURPOSE: Phase I trial to study the effectiveness of testosterone in treating patients who have progressive prostate cancer that no longer responds to hormone therapy.


Study summary:

OBJECTIVES: - Determine the safety and maximum tolerated dose of exogenously administered testosterone in patients with progressive androgen-independent prostate cancer who have been in castrate state either surgically or pharmacologically for a minimum of 1 year. - Assess the changes in expression of androgen receptor and other receptors in human biopsy specimens or circulating tumor cells before and after this treatment in this patient population. OUTLINE: This is a dose-escalation study. Patients receive testosterone via an enhanced absorption transdermal system continuously for 28 days. The transdermal patches are changed daily. Cohorts of 3-6 patients receive a fixed daily dose of testosterone with escalating duration of exposure until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities. Patients are followed at day 1 and at weeks 2 and 4. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed androgen independent metastatic prostate cancer - Progressive disease manifested by either: - New osseous lesions by bone scan or a greater than 25% increase in bidimensionally measurable soft tissue disease or the appearance of new sites of disease by MRI or CT scan OR - Minimum of 3 rising PSA values from baseline that are obtained 1 week or more apart, or 2 rising PSA values more than 1 month apart, where the percentage increase over the range of values is at least 25% - Castrate state by orchiectomy or gonadotropin-releasing hormone analogues for minimum of 1 year - Testosterone no greater than 30 ng/mL - Measurable disease - Metastatic disease by bone scan, MRI, or CT scan - Rising PSA values - If receiving antiandrogen therapy, must have shown progressive disease off treatment - No active CNS or epidural tumor PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 2.0 mg/dL - SGOT less than 3 times upper limit of normal - PTT less than 14 seconds Renal: - Creatinine less than 2.0 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No New York Heart Association class III or IV cardiac disease Pulmonary: - No severe debilitating pulmonary disease Other: - No infection requiring IV antibiotics - No other severe medical problems that would increase risk for toxicity PRIOR CONCURRENT THERAPY: Biologic therapy: - Recovered from prior biologic therapy - No concurrent immunotherapy Chemotherapy: - Recovered from prior chemotherapy - No concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - If no prior orchiectomy, must continue on gonadotropin-releasing hormone analogs to maintain castrate levels of testosterone - No concurrent finasteride - No other concurrent hormonal therapy Radiotherapy: - Recovered from prior radiotherapy - No concurrent radiotherapy to an indicator lesion Surgery: - See Disease Characteristics - Recovered from prior surgery - No concurrent surgery on only measurable lesion Other: - At least 4 weeks since other prior investigational anticancer drugs and recovered - No other concurrent investigational anticancer agents


NCT ID:

NCT00006044


Primary Contact:

Study Chair
Michael Morris, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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